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Instructions for Use

Universal Battery Charger II.

Universal Battery Charger II Instructions for Use DePuySynthes 1

Table of Contents

Introduction

Description of the Controls

Operating the Device

General Information 3– Intended use 3– Compatibility 3– Abbreviations 3– Safety precautions 4– Scope of delivery 5– Storage and transport 5– Warranty 5

– Front view 6– Rear view 6

Starting the System 7

Charging the Battery 8– Charger bay 8– Charging the battery 9– Temperature monitoring 10– Charging new batteries 10or batteries not recently used

– Errors during charging 10

Checking and Refreshing Batteries 11– Battery Power Line and Colibri / 11Small Battery Drive batteries

– Battery Power Line II and Colibri II / Small Battery Drive II batteries 13

– Trauma Recon System power module 15

Storing Batteries 16

Slot Covers Set 17

2 DePuySynthes Universal Battery Charger II Instructions for Use

Care and Maintenance

Troubleshooting

Technical Data

Explanation of Symbols Used

Ordering Information

Cleaning 18

Repair and Technical Service 19

Disposal 20

21

Device Specifications 24

Minimum required Firmware version of UBC II 25

Environmental Conditions 26

Applicable Standards 27

Electromagnetic Compatibility – 28Accompanying Documents in Accordance with EN / IEC 60601-1-2, Clause 5.2.2

Permissible Battery Types 32– Battery for Battery Power Line 32– Battery for Battery Power Line II 32– Power module for Trauma Recon System 32– Batteries for Colibri / Small Battery Drive 33– Battery for Colibri II / Small Battery Drive II 33

Symbols for Operating the Charger 34

Symbols on the Charger 35

36

Table of Contents


Intended useThe Universal Battery Charger II (05.001.204), referred tohenceforth as the charger or device, allows the followingSynthes batteries to be automatically charged and manuallychecked:

Introduction General Information

System Handpieces Battery / Power Module

Battery Power Line 530.605 530.620 (14.4 V, NiMH)530.610530.615

Battery Power Line II 530.705 530.630 (14.8 V, Li-Ion)530.710530.715

Trauma Recon System 05.001.201 05.001.202 (25.2 V, Li-Ion)05.001.240

Colibri / Small Battery Drive 532.001 532.003 (12 V, NiCd)532.010 532.033 (14.4 V, NiCd)

Colibri II / Small Battery Drive II 532.101 532.103 (14.4 V, Li-Ion)532.110

If required, Battery Power Line battery (530.620) and Colibri /Small Battery Drive batteries (532.003, 532.033) can also berefreshed with the charger (see page 11 ff).

Compatibility The Colibri / Small Battery Drive batteries (532.003, 532.033)can be used with Colibri II / Small Battery Drive II handpiece(532.101, 532.110).

The Colibri II / Small Battery Drive II battery (532.103) can beused with the Colibri / Small Battery Drive handpiece(532.001, 532.010).

The Battery Power Line battery (530.620) can be used withthe Battery Power Line II handpieces (530.705, 530.710,530.715).

The Battery Power Line II battery (530.630) can be used withthe Battery Power Line handpieces (530.605, 530.610,530.615).

Precaution: The battery for the Power Drive (530.200) cannot be charged with the UBC II. Please use the UBC item number 530.600 or 530.601.

AbbreviationsPlease note the below mentioned items are abbreviatedthroughout the document as follows:

Items Abbreviation

Colibri / Small Battery Drive Colibri / SBD

Colibri II / Small Battery Drive II Colibri II / SBD II

Power Module for Trauma Recon System Power Module

Universal Battery Charger II UBC II


Safety precautionsThe device may only be used with the supplied power cord.

The device may only be operated on an even, dry surfacethat is sufficiently strong to hold its weight.

Avoid contact with fluids.

The device is designed to be operated and stored in closedrooms. Ensure that the device is not operated in the directvicinity of radiators or other heat emitting devices (please refer to page 26 for details on environmental conditions).

Please observe the information on the electromagnetic compatibility, see page 28 ff.

The device may only be used for the authorized Synthes batteries.

Before operating the device, check that it is in sound condi-tion and is working properly.

If it is not in perfect working order, contact the Synthes representative. Do not use a damaged or faulty device.

Introduction General Information

1.5 m1.5 m

1.5 m

2.5 m


Precautions: – Only use the Synthes Universal Battery Charger II(05.001.204) to charge the batteries. Using a charger thatdoes not originate from Synthes can damage the battery.

– Do not open device. Risk of fatal injury due to electric shock!

– Do not use the device in the sterile area of the operatingroom.

– The device must not come into direct or indirect contactwith the patient.

– Do not use the device in patient vicinity. The patient vicin-ity is an area 2.5 m above and 1.5 m next to the patient (see fig. on the right).

– Do not wash the device in a washer/disinfector. The devicemust not be sterilized. Please see page 18 for informationon cleaning and maintenance.

– Do not operate the device in the presence of a flammableanesthetics mixture with air or oxygen or with nitrous oxide.

– Do not expose the device to direct sunlight or moisture. – The charging station should always be turned on when a battery is in the charging bay. This ensures availabilityand prevents discharge.

Scope of deliveryThe Universal Battery Charger II consists of the charger(05.001.204), the supplied, country-specific power cord andfour slot covers sets (05.001.228). The device may only beused with the supplied power cord.

Storage and transportAll batteries should be removed for transporting the charger.

Use the original packaging for shipping and transport. If thisis no longer available, please contact the Synthes represen -tative.

The same environmental conditions apply for transport as forstorage, see page 26.

WarrantyThe warranty for the device is null and void if the device hasnot been used properly or the guarantee seal has been dam-aged. The manufacturer does not accept liability for damageresulting from repairs or maintenance carried out by un -authorized sites. For a complete warranty statement, pleasecontact Synthes Customer Service.

87

9

6

43

5

12


Front view1 Charger bays (24)2 Symbols for battery type3 ON/OFF display4 Control display for each charging bay5 Ventilation holes

Description of the Controls

Rear view6 Ventilation holes7 Power switch8 Fuses: 225 AT / 250 V9 Power cord connection


Before starting for the first time, ensure that the powerswitch is set to . The device can only be connected to thepower supply using the supplied power cord. Set the powerswitch to I to turn the device on (fig.1). The ON/OFF displaylight on the front of the device shows that it is working properly (fig. 2). If the display flashes, the device must besent in for control.

If the red display light for a single charger bay lights up(fig. 3) before the battery is inserted, this charger bay is faulty.In this case, batteries can still be charged in the othercharger bays, but it is recommended that the device be sentto the local Synthes representative for repairs.

Precautions: – Place the device on a non-slip, stable base. Ensure that theventilation holes in the base of the device are not covered by towels or other objects.

– Do not position the device so that it is difficult to separatethe power cord from the supply mains.

– Do not operate the device in the direct vicinity of radiatorsor other heat emitting devices, as these can affect the device.

– Do not expose the device to direct sunlight or moisture.– Do not cover the side ventilation holes on the device.– Only connect to a power supply with earthing, a ratedvoltage between 100 V and 240 V and a network frequency range of 50 or 60 Hz.

Operating the Device Starting the System

Fig. 1

Fig. 2

Fig. 3

2

3

1


Charging the Battery


Charger bayThe device is fitted with four independent charger bays. Eachof these has three slots for the following batteries (fig. 1):

1 Battery Power Line and Battery Power Line II batteries (530.620, 530.630) 2 Trauma Recon System Power Module (05.001.202) 3 Colibri / SBD and Colibri II / SBD II batteries (532.003, 532.033, 532.103)

Fig. 1


Fig. 2

Fig. 3

Charging the batteryPlace the battery to be charged in the proper direction intothe corresponding slot of an empty charger bay. Only onebattery can be charged in each charger bay at a time. All charger bays can, however, be used simultaneously withany combination of battery types.

Once the battery types have been identified the chargingprocess starts automatically. This is signalled by the yellowcharger display (fig. 2).

Depending on the charge status and type of battery, it cantake from about 15 minutes to around 60 minutes to charge.

Once the battery is fully charged, the green display lights up and the charger switches to maintenance charge (fig. 3). The battery can be left in the charger. Leave the device switched on to ensure that the battery is alwaysfully charged.

If the battery is removed from the charger before the greendisplay lights up, it will not be fully charged.

Precautions: – Insert the battery into the correct slot.– Ensure that the battery is fitted correctly and is identifiedby the device (yellow charger display lights up).

– If the display does not light up after the battery is inserted,remove the battery and insert again or insert into anothercharger bay.

– Do not insert any objects other than batteries into thecharger, as the contacts may otherwise be damaged.

flashing


Temperature monitoringThe battery and the charger heat up during the chargingprocess. The ventilation holes should therefore not be covered.

If the battery temperature is too high, the yellow charger display starts flashing (fig. 4). To protect the battery, thedevice stops charging until the battery has cooled down. Do not remove the battery from the charger if this occurs until the yellow charger display lights up constantly. Thecharging time will be longer in this case.

Charging new batteries or batteries not recently usedBattery Power Line battery (530.620) or Colibri / SBD batter-ies (532.003, 532.033) that have not been used for a longperiod of time and that have not been stored in an activatedcharger do not reach their maximum performance for severalcharging and discharging cycles. In case of doubt, thecharger can be used to check the battery status and to re-fresh the battery (see page 11 ff).

Errors during chargingThe following errors may occur while charging a battery:

Yellow display light flashes (fig. 4)The battery is too hot and has to cool down before thecharging process can be automatically resumed. The batterycan be left in the charger.

Red display light lights up (fig. 5)The battery is faulty and has to be replaced.

No display lightThe battery has not engaged in the charging bay or has notbeen recognized by the device. Remove the battery and in-sert again or use another charger bay.

Precautions: – Do not charge mechanically damaged batteries in thecharger.

– Only charge batteries authorized for the device (see page 32 ff).

– Only use fully charged batteries to avoid delays during surgery.

Operating the Device Charging the Battery

Fig. 4

Fig. 5


Checking and Refreshing Batteries


Battery Power Line and Colibri / SBD batteriesThe charger enables Battery Power Line battery (530.620)and Colibri / SBD batteries (532.003, 532.033) to be re-freshed and checked.

It will be indicated if the battery performance is sufficient orif the battery needs to be replaced.

The following factors will affect the battery performance

– Unused, new battery– Battery not used for a longer period

In these cases a battery will only reach its maximum per-formance after several charging and discharging cycles.The check and refresh function ensures that the batteryregains its maximum performance again.

– Old battery

The battery performance declines with age and usage.With the check function it can be seen if the battery performance is sufficient. However, due to the age of thebattery it is no longer possible to refresh it.

When required, the check and refresh function is startedmanually, as outlined below.

After the battery is inserted, the yellow charger display lights up. To refresh and check the battery, press the buttonwith the exclamation mark for at least 2 seconds (fig. 1)until the yellow display light lights up (fig. 2). The devicethen carries out the process. The yellow display lights upthroughout this time.

Fig. 1

Fig. 2


Operating the Device Checking and Refreshing Batteries

Completion of the process is indicated as follows:– Green display light (fig. 3): Battery has been success-fully refreshed, checked and charged.

– Red display light (fig. 4): Either the battery is faulty orperformance is insufficient. The battery must be disposedof.

The entire process (refreshing and checking batterystatus) takes around 10 hours and should only be carried out if there is enough time to do so.

A battery can be charged, checked or refreshed independ-ently in each charger bay.

Precautions: – To recharge batteries normally, do not press the exclama-tion mark button .

– Checking the battery status and refreshing the batteryhave an impact on the battery. If this is carried out frequently the lifespan of the battery can be affected.

– Do not remove the battery from the charger bay as longas the yellow display lights up (fig. 2 on previous page).Wait until the process has ended and the green or reddisplay lights up. Only then is the battery status clearlyassessed.

– The process is interrupted if there is a power cut or aswitch to the emergency power supply and will then haveto be restarted.

Fig. 3

Fig. 4


Battery Power Line II and Colibri II / SBD II batteriesThe charger enables Battery Power Line II and Colibri II / SBD II batteries (530.630, 532.103) to be checked. It will beindicated if the battery performance is sufficient or if the battery needs to be replaced.

Due to the very low self-discharging rate of Lithium-basedbatteries a refresh function is not required.

When required, the check function is started manually, asoutlined below.

After the battery is inserted, the yellow charger display lights up. To check the battery, press the button with the exclamation mark for at least 2 seconds (fig. 5) until theyellow display light lights up (fig. 6). The device then carries out the process. The yellow display lights upthroughout this time.

Fig. 5

Fig. 6


Completion of the process is indicated as follows:– Green display light (fig. 7): Battery has been success-fully checked and charged.

– Red display light (fig. 8): Either the battery is faulty orperformance is insufficient. The battery must be disposedof.

The entire process (checking battery status) takes around 3 hours and should only be carried out if there is enoughtime to do so.

A battery can be charged or checked independently in eachcharger bay.

Precautions: – To recharge batteries normally, do not press the exclama-tion mark button .

– Checking the battery status has an impact on the battery. If this is carried out frequently the lifespan of the batterycan be affected.

– Do not remove the battery from the charger bay as longas the yellow display lights up (fig. 6 on previous page).Wait until the process has ended and the green or reddisplay lights up. Only then is the battery status clearlyassessed.

– The process is interrupted if there is a power cut or aswitch to the emergency power supply and will then haveto be restarted.

Fig. 7

Fig. 8

Operating the Device Checking and Refreshing Batteries


Trauma Recon System power moduleTo ensure that the Trauma Recon System (05.001.201,05.001.240) can operate safely and reliably, the Trauma Recon System power module (05.001.202) has to bechecked at periodical intervals. It will be indicated if thepower module performance is sufficient or if the powermodule needs to be replaced.

The charger will indicate the necessity, but the user canchoose a convenient time to check the power module, as this can take around 4 hours.

When it needs to be checked, the yellow display light flashes (fig. 9). The check needs to be carried out within thenext 3 charging cycles. This is done by pressing the ex -clamation mark button for at least 2 seconds (fig. 10). Theyellow charger display goes out and the display changes from flashing to lighting up (fig. 11). If the check isnot carried out within the next 3 charging cycles, the devicecarries out the check automatically.

Completion of the process is indicated as follows:– Green display light (fig. 7 on previous page): powermodule has been checked, charged and is ready to use.

– Red display light (fig. 8 on previous page): power module has been checked, is not charged and cannot beused; the red service indicator lamp on the power modulelights up. Send in the power module for servicing.

A power module can be charged or checked independentlyin each charger bay.

Precautions: – If the check is not carried out within the next 3 chargingcycles, the charger starts this process automatically. The yellow display lights up (fig. 11).

– It takes around 4 hours to check the power module.

Fig. 9

Fig. 10

Fig. 11

flashing

flashing


Immediately recharge batteries and the power module aftereach use.

Any Colibri / SBD batteries (532.003, 532.033) or BatteryPower Line battery (530.620) that are not used should always be stored in the activated charger (maintenancecharge). This guarantees that the batteries are always fullycharged and ready to use.

It is not necessary to store Trauma Recon System powermodule (05.001.202), Battery Power Line II battery (530.630)and Colibri II / SBD II battery (532.103) in the charger. Oncecharged they can be stored outside the charger without anynoticeable charge difference due to a very low self-discharg-ing rate of Lithium-based batteries.

Precautions: – Do not use batteries / power modules that are not fullycharged. A partial charge may not be sufficient for the intended use.

– Unusable or faulty batteries / power modules should notbe used. They should be disposed of (see section “Disposal” on page 20).


Storing Batteries


The Slot Covers Set (05.001.228) consists of three plastic ele-ments which were developed to cover the non-used slots of the charger (fig. 1). A Slot Cover helps to insert a batteryor power module much easier into the Universal BatteryCharger II because it covers the unused slots of the charger(fig. 2). Therefore, it prevents to insert the appropriate bat-tery or power module into the wrong slot.


Slot Covers Set

Fig. 1

Fig. 2


The device must be unplugged before it is cleaned. Occa-sionally wipe down the device with a dry cloth. If it is verydirty the device can be cleaned with a slightly damp cloth.Dry well. Do not use solvents.

Whenever it is cleaned the device should be checked to ensure it is working properly and is not damaged.

Maintenance of the device is not required.

If there are any faults, please send the device to a Synthesrepresentative (see next section).

Precautions: – Danger of electric shock! Unplug before cleaning.– Do not wash the device in a washer/disinfector.– Device must not be sterilized.– Make sure that no solution enters the device.– If necessary, clean the contacts in the charger bays usingutmost care.

Care and Maintenance Cleaning


The device should be sent to the Synthes representative forrepair if it is faulty or malfunctions.

The same applies if the ON/OFF display does not light up orflashes when the device is switched on.

To prevent damage during shipping use the original packag-ing to return devices back to Synthes. If this is not possible,please contact the Synthes representative.

Users or third parties should not carry out repairs themselves.

Precaution: The manufacturer shall assume no responsibilityfor damage resulting from unauthorized repair.


Repair and Technical Service


In most cases faulty chargers can be repaired (see previoussection “Repair and Technical Service”).

The European directive 2002/96/EC on waste electri-cal and electronic equipment (WEEE) applies to thisdevice. This device contains materials that should be disposed of in accordance with environment protection requirements. Please observe national and local regulations.

Please send devices that are no longer used to the local Synthes representative. This ensures that they are disposed of in accordance with the national application of the respective directive. The charger may not be disposed of with house-hold waste.

Faulty batteries may not be reused and should be disposedof in an environmentally friendly manner and in accordancewith national regulations.

Only return Trauma Recon System power module(05.001.202) to the Synthes representative, observing theapplicable instructions for use.


Disposal


Troubleshooting

ON/OFF display does not light up.

ON/OFF display flashes.

Although the battery / power module isinserted there is no display light for thecharger bay.

Red display lights up when the bat-tery / power module is inserted.

Switch on power switch.

Connect power cord to the connectionon the charger and plug into the wall socket.Then switch on the powerswitch on the charger.

Check power supply. Replace fuse if necessary.

Send the charger to the Synthes representative for repairs.


Ensure that the battery / power moduleis inserted properly.

Carefully clean contacts.

Use another free charger bay.

Test the battery / power module in another charger bay and dispose of ifnecessary.


Replace battery / power module.

Check firmware version on the sticker,which is visible on the underside of thecharger and compare with the mini-mum required firmware listed on page 25. Send the charger to Synthesre presentative for a software update.

Charger is switched off.

Power cord is not plugged in.

Power supply is interuppted (e.g. faulty fuse).

Charger is faulty.

Charger is faulty.

Battery / power module is not fully inserted.

Contacts in the charger bay are dirty.

Battery / power module was not recog-nized by the charger.

Battery / power module is faulty.

Charger bay is faulty.

Battery / power module is faulty.

Firmware has to be updated

Problem Possible cause Solution

Troubleshooting

Red display lights up when thecharger is switched on before the bat-teries / power modules are inserted.

Yellow display flashes during thecharging process.

Yellow display does not light upwhen the button is pressed.

It is not possible to insert the battery /power module into the slot.

Charger makes loud noises.



Battery / power module is too hot.

Button was released too soon.


Charger has an error.

Wrong slot.

Non-authorized battery / power module.

Contacts in the slot bent.

Ventilation holes on the sides, back orbase are covered and/or the device isnext to a heat source. Automatic cool-ing is on full power.

Use another free charger bay. Send the charger to the Synthes affiliate for repairs as soon as possible.

Leave battery / power module insertedin the charger bay. Charger automati-cally continues the charging processonce the battery / power module hascooled down.

Hold button down for at least 2 seconds.

Select another free charger bay. Sendthe device to the Synthes represen -tative for repairs as soon as possible.

Switch off charger, then switch back onafter 5 seconds. If the ON/OFF displayflashes, send the device to the Synthesrepresentative for repairs.

Select correct slot and re-insert battery / power module.

Check battery / power module type.

Use another free charger bay. Send the charger to the Synthes representa-tive for repairs as soon as possible.

Expose ventilation holes and/or ensurethat the device is not next to a heatsource.


Battery / power module performance is low.

Battery / power module is visibly damaged.


Insufficient battery / power module status.

Expected battery / power module life is reached.

Battery / power module is not ready for use.

Power Tool or attachment is sluggish,i.e. as a result of insufficient mainte-nance.

Battery / power module was exposedto excessive heat.

Battery / power module was washed,disinfected or sterilized.

Battery / power module was short-fused by metal objects.

Battery / power module fell on the floor.

Refresh battery (see page 11 ff). Onlypossible with Battery Power Line battery (530.620) and Colibri / SBD batteries (532.003, 532.033).

Test battery / power module (see page11 ff). If the red display lights up, replace battery / power module.

Charge battery / power module untilgreen display lights up.

Send Power Tool and attachments toSynthes representative to be checked.





Please also observe the instructions for use of the corresponding Power Tools.

If the recommended solutions do not work, please contact your Synthes representative.


Subject to technical modifications


Technical Data Device Specifications

Dimensions (L2B2H) 310 mm 2 220 mm 2 175 mm

Weight 4.8 kg

Operating voltage 100 V – 240 V, 50/60 Hz

Operating current 1.2–2.8 A AC

Mains rated input 250 W

Protection class I, EN/IEC 60601-1 (2005+Corr:07)

Protection type by casing IPX0, EN/IEC 60601-1 (2005+Corr:07)

Fuses 225 AT / 250 V

Operating mode Continuous operating mode

Sterilization Device must not be sterilized

System Battery / power module Minimum required Firmware version of UBC II

Battery Power Line 530.620 (14.4 V, NiMH) 2.0 (no sticker on the underside of the charger)

Trauma Recon System 05.001.202 (25.2 V, Li-Ion) 2.0 (no sticker on the underside of the charger)

Colibri / Small Battery Drive 532.003 (12 V, NiCd) 2.0 (no sticker on the underside of the charger) 532.033 (14.4 V, NiCd) 2.0 (no sticker on the underside of the charger)

Colibri II / Small Battery Drive II 532.103 (14.4 V, Li-Ion) 11.0 (sticker visible on the underside of the charger*)

Battery Power Line II 530.630 (14.8 V, Li-Ion) 14.0 (sticker visible on the underside of the charger*)


Technical Data

Minimum required Firmware version of UBC II

In order that the different battery types can be recognizedand charged by UBC II the correct Firmware version is re-quired. The table below outlines the requirements for eachbattery type. If required, send the charger to a Synthes representative for a firmware update.

*Sticker as shown on the underside of the charger withFirmware version 11.0 SW-Rev.11.0

2010/08 /04


Technical Data

Environmental Conditions

Precaution: The device is not suitable for use in the pres-ence of a flammable anesthetics mixture with air or oxygenor with nitrous oxide.

Operation Storage Transport

Temperature 40 °C 50 °C 60 °C 104°F 122°F 140°F 10 °C –20 °C –29 °C for max. 50 °F –4 °F –20 °F 72 hours

Relative humidity 90 % 90 % 90 %

30% 10% 10%

Atmospheric pressure 1060 hPa 1060 hPa 1060 hPa

700 hPa 500 hPa 500 hPa

Altitude 0 –3000 m 0 –5000 m –

10PB


Technical Data

Applicable Standards

The device meets the following standards:

EN/IEC 60601-1 3rd Edition

Universal Battery Charger IIWith respect to electrical shock, fire and mechanical hazards only in accordance with ANSI/AAMI ES60601-1 (2005+C1+A2)CSA C22.2 No 60601.1 (2008)

EN/IEC 60601-1 3rd Edition

Universal Battery Charger IIWith respect to electrical shock, fire andmechanical hazards only in accordance withANSI/AAMI ES60601-1 (2005+C1+A2)CSA C22.2 No 60601.1 (2008)EN/IEC 60601-1 (2005+Corr:07)

Technical Data

Electromagnetic Compatibility –Accompanying Documents inAccordance with EN/IEC 60601-1-2,Clause 5.2.2


Guidelines and manufacturer’s declaration – electromagnetic emissions

The Synthes Universal Battery Charger II is intended for use in the electromagnetic environment specified below. The customer or the user of the Synthes Universal Battery Charger II should assure that it is used in such an environment.

Emission tests

RF emissionsCISPR 11

RF emissionsCISPR 11

Harmonic emissionsIEC 61000-3-2

Voltage fluctuations / flicker emissionsIEC 61000-3-3

Compliance

Group 1

Class B

Class A

Complies

Electromagnetic environment – guidance

The Synthes Universal Battery Charger II uses RFenergy only for its internal function. Therefore, itsRF emission is very low and it is not likely to causeany interference in nearby electronic equipment.

The Synthes Universal Battery Charger II is suitablefor use in all establishments, including domesticestablishments and those directly connected tothe public low-voltage power supply network thatsupplies buildings used for domestic purposes.

Table 1: Emissions

Guidelines and manufacturer’s declaration – electromagnetic immunity


Immunity test standard

Electrostatic discharge (ESD)IEC 61000-4-2

Electrical fast transient / burstIEC 61000-4-4

SurgeIEC 61000-4-5

Voltage dips, short interrup-tions and voltage variations on power supply linesIEC 61000-4-11

Note: UT is the A.C. mains voltage prior to application of the test level.

Power frequency (50/60 Hz)magnetic fieldIEC 61000-4-8

IEC 60601test level

±6 kV contact±8 kV air

±2 kV for powersupply lines

±1 kV for signallines

±1 kV line to line

±2 kV line toearth

<5 % UT(0.5 cycle)

40 % UT (5 cycles)

70 % UT(25 cycles)

<5 % UT for 5 s

3 A/m


Floors should be wood, concrete or ceramic tile. If the floors are covered with synthetic material,the relative humidity should be at least 30%.

Mains power quality should be that of a typicalcommercial or hospital environment.

Mains power quality should be that of a typicalcommercial or hospital environment.

Mains power quality should be that of a typicalcommercial or hospital environment. If the user of the Synthes Universal Batter Charger II requirescontinued operation during power mains inter -ruptions, it is recommended that the Synthes Universal Battery Charger II is powered from anUPS.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Table 2: Immunity (all devices)

Compliancelevel

±8 kV contact±8 kV air

±2 kV for powersupply lines

±1 kV line to line

±2 kV line toearth

<5 % UT(0.5 cycle)

40 % UT (5 cycles)

70 % UT(25 cycles)

<5 % UT for 5 s

30 A/m


Technical Data Electromagnetic Compatibility – Accompanying Documentsin Accordance with EN/IEC 60601-1-2, Clause 5.2.2


Guidance and manufacturer’s declaration – electromagnetic immunity



Portable and mobile RF communications equipment should be used no closer to any part of the Synthes Universal BatteryCharger II, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Immunity teststandard

Conducted RFIEC 61000-4-6

Radiated RFIEC 61000-4-3

Radiated RFIEC 61000-4-3

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters as determined by an electromagnetic site survey, a

should be less than the compliance level in each frequency range. b

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radiobroadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagneticsite survey should be considered. If the measured field strength in the location in which the Synthes Universal Battery Charger II is used exceeds the applicable RFcompliance level above, the Synthes Universal Battery Charger II should be observed to verify normal operation. If abnormal performance is observed, additional measuresmay be necessary, such as re-orienting or relocating the Synthes Universal Battery Charger II.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

IEC 60601test level

3 Vrms150 kHz to 80 MHz

3 V/m80 MHz to 800 MHz

3 V/m800 MHz to 2.5 GHz

Recommended separation distance

d = 0.35 =+P150 kHz to 80 MHz

d = 0.35 =+P80 MHz to 800 MHz

d = =+P800 MHz to 2.7 GHz

Table 4: Immunity (not life-supporting devices)

Compliancelevel

V1 = 10 Vrms150 kHz to 80 MHz

E1 = 10 V/m80 MHz to 800 MHz

E2 = 7 V/m800 MHz to 2.7 GHz

Recommended separation distances between portable and mobile RF communications equipment and the Synthes Universal Battery Charger II

The Synthes Universal Battery Charger II is intended for use in the electromagnetic environment in which radiated RF distur-bances are controlled. The customer or the user of the Synthes Universal Battery Charger II can help prevent electromagneticinterference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)and the Synthes Universal Battery Charger II as recommended below, according to the maximum output power of the communication equipment.

Rated maximum output power of transmitterW

0.01

0.1

1

10

100

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m)can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output powerrating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

m

150 kHz to 80 MHzd = 0.35 =+P

3.5 cm

11 cm

35 cm

1.1 m

3.5 m

800 MHz to 2700 MHzd = =+P

10 cm

32 cm

1 m

3.2 m

10 m

Table 6: Recommended separation distances (not life-supporting devices)

80 MHz to 800 MHzd = 0.35 =+P

3.5 cm

11 cm

35 cm

1.1 m

3.5 m

Separation distance according to frequency of transmitter



Battery for Battery Power Line

Art. no. 530.620

Operating voltage (rated) 14.4 V

Battery capacity 2 Ah / 28.8 Wh

Battery NiMH

Typical charging time <60 min

Power module for Trauma Recon System

Art. no. 05.001.202


Battery capacity 1.2 Ah / 30.24 Wh

Battery Li-Ion



Technical Data

Permissible Battery Types

Battery for Battery Power Line II

Art. No. 530.630



Battery Li-Ion



Batteries for Colibri / Small Battery Drive

Art. no. 532.003 532.033

Operating voltage (rated) 12 V 14.4 V

Battery capacity 0.5 Ah / 6 Wh 0.5 Ah / 7.2 Wh

Battery NiCd NiCd

Typical charging time <60 min <60 min


Battery for Colibri II / Small Battery Drive II

Art. no. 532.103



Battery Li-Ion


Precaution: The battery for the Power Drive (530.200) cannot be charged with the UBC II. Please use the UBC itemnumber 530.600 or 530.601.

Battery is charged. The charger has switched tomaintenance charge and checks that the battery isalways fully charged and ready to use.

Lighting display: the battery is partially charged. The charging process is not completed.Flashing display: the battery is too hot (see page 10).

The battery is faulty and has to be replaced (seepage 10) or the charger bay is faulty (see page 7).

Button to check and refresh batteries (see page 11)and to check Battery Power Line II, Colibri II / SBD IIbatteries or power modules (see page 13 ff).

Lighting display: the process to check and refreshbatteries (see page 11) and to check Battery PowerLine II, Colibri II / SBD II batteries or power modules(see page 13 ff) is on going.Flashing display: the inserted Trauma Recon Systempower module should be checked (see page 15).

Symbol for Battery Power Line and Battery Power Line II batteries (530.620, 530.630)

Symbol for Trauma Recon System power module (05.001.202)

Symbol for Colibri / SBD and Colibri II / SBD II batteries (532.003,532.033, 532.103)

Explanation of Symbols Used Symbols for Operating the Charger


2x5AT/250Vbreaking capacity

capacité de rupture150A / 250V

SW-Rev.11.02010/08 /04

non sterile

10PB


Read the provided instructions for use before operating the device.

Caution

The European directive 2002/96/EC on waste electrical and electronic equipment (WEEE) appliesto this device. This device contains materials that should be disposed of in accordance with environment protection requirements. Please observe national and local regulations. See section entitled “Disposal” on page 20.

Date of manufacture

Universal Battery Charger IIWith respect to electrical shock, fire and mechani-cal hazards only in accordance with ANSI/AAMI ES60601-1 (2005+C1+A2)CSA C22.2 No 60601.1 (2008)

Universal Battery Charger IIWith respect to electrical shock, fire and mechani-cal hazards only in accordance with ANSI/AAMI ES60601-1 (2005+C1+A2)CSA C22.2 No 60601.1 (2008)EN/IEC 60601-1 (2005+Corr:07)

The device meets the requirements of directive93/42/EEC for medical devices. It is authorized byan independent named site for which it bears theCE symbol.

Explanation of Symbols Used

Symbols on the Charger

Firmware version of UBCII (see page 25)

Fuses: 225 AT / 250 V

Non sterile

Temperature (see page 26)

Relative humidity (see page 26)

Atmospheric pressure (see page 26)

Do not use if package is damaged

Battery charger

05.001.204 Universal Battery Charger II

Batteries

530.620 Battery for Battery Power Line, 14.4 V

530.630 Battery for Battery Power Line II

05.001.202 Power Module, for Trauma Recon System

532.003 Battery for Nos. 532.001 and 532.010, 12 V, standard

532.033 Battery for Nos. 532.001 and 532.010, 14.4 VDC

532.103 Battery for Nos. 532.101 and 532.110

Power cord

05.001.136 Power Cord, three-pole, Europe

05.001.137 Power Cord, three-pole, Australia

05.001.138 Power Cord, three-pole, Great Britain

05.001.139 Power Cord, three-pole, Denmark

05.001.140 Power Cord, three-pole, North America

05.001.141 Power Cord, three-pole, Switzerland

05.001.142 Power Cord, three-pole, India, South Africa

05.001.143 Power Cord, three-pole, Italy

05.001.144 Power Cord, three-pole, China

05.001.145 Power Cord, three-pole, Japan

05.001.146 Power Cord, three-pole, Argentina

05.001.147 Power Cord, three-pole, Israel

Slot Covers Set

05.001.228 Slot Covers Set for Universal Battery Charger II

Ordering Information


0123

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er Tools, a division of Synthes GmbH. 2014. All rights reserved. 036.000.500

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